Clearance Summary
SYNERGY TISSUE MATRIX received FDA 510(k) clearance under submission number K113460, sponsored by Synovis Orthopedic & Woundcare. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2012-01-11.
- Submission: K113460
- Applicant / Sponsor: Synovis Orthopedic & Woundcare
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2012-01-11
Classification & Regulation
This clearance is catalogued under FDA product code FTM and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.